Malta - English - Medicines Authority

macleods pharma uk ltd wynyard park house, wynyard avenue, wynyard, billingham ts22 5tb , united kingdom - colchicine - film-coated tablet - colchicine 1000 µg - antigout preparations

Malta - English - Medicines Authority

wockhardt uk limited - colchicine - tablet - colchicine 500 µg - antigout preparations

Malta - English - Medicines Authority

pinewood laboratories limited ballymacarbry, clonmel, co. tipperary, ireland - colchicine - tablet - colchicine 500 µg - antigout preparations

Ireland - English - HPRA (Health Products Regulatory Authority)

renata (uk) limited - colchicine - tablet - 500 microgram(s) - preparations with no effect on uric acid metabolism; colchicine

Ireland - English - HPRA (Health Products Regulatory Authority)

renata pharmaceuticals (ireland) limited - colchicine - tablet - 500 microgram(s) - preparations with no effect on uric acid metabolism; colchicine

Israel - English - Ministry of Health

rafa laboratories ltd - colchicine - tablets - colchicine 500 mcg - colchicine - colchicine - prevention and treatment of gout and fmf (familial mediterranean fever).

United States - English - NLM (National Library of Medicine)

granules pharmaceutical inc. - colchicine (unii: sml2y3j35t) (colchicine - unii:sml2y3j35t) - colchicine capsules are indicated for prophylaxis of gout flares in adults. limitations of use: the safety and effectiveness of colchicine capsules for acute treatment of gout flares during prophylaxis has not been studied. colchicine capsules are not an analgesic medication and should not be used to treat pain from other causes. patients with renal or hepatic impairment should not be given colchicine capsules with drugs that inhibit both p­glycoprotein and cyp3a4 inhibitors [see drug interactions (7) ]. combining these dual inhibitors with colchicine in patients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity. patients with both renal and hepatic impairment should not be given colchicine capsules. pregnancy category c . there are no adequate and well-controlled studies with colchicine capsules in pregnant women. colchicine crosses the human placenta. developmental studies in animals were not conducted with colchicine capsules, however published animal reproduction and development studies with colchicine demonstrated embryofetal toxicity, teratogenicity, and altered postnatal development at exposures within or above the clinical therapeutic range. colchicine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. the effect of colchicine on labor and delivery is unknown. colchicine is excreted into human milk. limited information suggests that infants exclusively breastfed receive less than 10 percent of the maternal weight-adjusted dose. while there are no published reports of adverse effects in breast-feeding infants of mothers taking colchicine, colchicine can affect gastrointestinal cell renewal and permeability. caution should be exercised and breastfeeding infants should be observed for adverse effects when colchicine capsules are administered to a nursing woman. gout is rare in pediatric patients; the safety and effectiveness of colchicine capsules in pediatric patients has not been evaluated in controlled studies. because of the increased incidence of decreased renal function in the elderly population, and the higher incidence of other co-morbid conditions in the elderly population requiring the use of other medications, reducing the dosage of colchicine when elderly patients are treated with colchicine should be carefully considered. no dedicated pharmacokinetic study has been conducted using colchicine capsules in patients with varying degrees of renal impairment. colchicine is known to be excreted in urine in humans and the presence of severe renal impairment has been associated with colchicine toxicity. urinary clearance of colchicine and its metabolites may be decreased in patients with impaired renal function. dose reduction or alternatives should be considered for the prophylaxis of gout flares in patients with severe renal impairment. colchicine is not effectively removed by hemodialysis. patients who are undergoing hemodialysis should be monitored carefully for colchicine toxicity. no dedicated pharmacokinetic study using colchicine capsules has been conducted in patients with varying degrees of hepatic impairment. colchicine is known to be metabolized in humans and the presence of severe hepatic impairment has been associated with colchicine toxicity. hepatic clearance of colchicine may be significantly reduced and plasma half-life prolonged in patients with chronic hepatic impairment. dose reduction or alternatives should be considered for the prophylaxis of gout flares in patients with severe hepatic impairment. tolerance, abuse, or dependence from colchicine has not been reported.

United States - English - NLM (National Library of Medicine)

par pharmaceutical, inc. - colchicine (unii: sml2y3j35t) (colchicine - unii:sml2y3j35t) - colchicine capsules are indicated for prophylaxis of gout flares in adults. limitations of use: the safety and effectiveness of colchicine for acute treatment of gout flares during prophylaxis has not been studied. colchicine is not an analgesic medication and should not be used to treat pain from other causes. patients with renal or hepatic impairment should not be given colchicine with drugs that inhibit both p­ glycoprotein and cyp3a4 inhibitors [see drug interactions (7 )]. combining these dual inhibitors with colchicine in patients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity. patients with both renal and hepatic impairment should not be given colchicine. pregnancy category c . there are no adequate and well-controlled studies with colchicine in pregnant women. colchicine crosses the human placenta. developmental studies in animals were not conducted with colchicine, however published animal reproduction and development studies with colchicine demonstrat

United States - English - NLM (National Library of Medicine)

chartwell rx, llc - colchicine (unii: sml2y3j35t) (colchicine - unii:sml2y3j35t) - colchicine tablets are indicated for prophylaxis and the treatment of acute gout flares. - prophylaxis of gout flares: colchicine tablets is indicated for prophylaxis of gout flares. colchicine tablets is indicated for prophylaxis of gout flares. - treatment of gout flares: colchicine tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare. colchicine tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare. colchicine tablets are indicated in adults and children four years or older for treatment of familial mediterranean fever (fmf). patients with renal or hepatic impairment should not be given colchicine tablets in conjunction with p-gp or strong cyp3a4 inhibitors (this includes all protease inhibitors except fosamprenavir). in these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. risk summary available data from published literature on colchicine use in p

United States - English - NLM (National Library of Medicine)

rxhomeo private limited d.b.a. rxhomeo, inc - colchicine (unii: sml2y3j35t) (colchicine - unii:sml2y3j35t) - rheumatic pain condition listed above or as directed by the physician